Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in healthy volunteers who have previously been vaccinated with the same concentration of rF1V vaccine.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant Plague Vaccine rF1V in Healthy Volunteers|
- To evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an IM injection at four ascending dose-levels.
- To evaluate immunogenicity of a two-dose schedule of rF1V vaccine when given as an IM injection at four ascending dose-levels
- To collect and store serum samples for future immunogenicity assays (e.g. ELISA).
|Study Start Date:||November 2004|
|Study Completion Date:||September 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
The Phase 1 clinical trial is designed as an open-label, single-center, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of a two-dose regimen of rF1V in healthy volunteers at four dose-levels (20 ug, 40 ug, 80 ug and 160 ug rF1V) in four sequential cohorts. The protocol was amended 26 January 2006 to recruit volunteers from Cohort 4 to participate in an Extension. Cohort 4 Extension volunteers will receive a third vaccination at day E-0. Day E-0 (-1) should not exceed Day 240 of the Phase 1 study.
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Richard N Greenberg, MD||University of Kentucky|